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Pv Medical Writing Manager/Team Lead Pv Medical Writing Manager/Team Lead (Pharmacovigilance Aggregate Reports)

0-2 years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

PV Medical Writing Manager/Team Lead (Pharmacovigilance Aggregate Reports) 

Location: Krakow, Poland
Employment Type: Full-Time
Department: Medical Writing
Company: PrimeVigilance (Part of Ergomed Group)

Company Description:
PrimeVigilance, a specialized mid-size pharmacovigilance service provider established in 2008, offers services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. The company has experienced continuous global growth, with a presence in Europe, North America, and Asia. PrimeVigilance collaborates with pharmaceutical and biotechnology partners across all therapy areas, including medical devices.

The company prioritizes employee well-being, professional development, and work-life balance, fostering a supportive environment that enables high-quality client service and meaningful contributions to patient safety.

Job Description:
The Senior Medical Writer position at PrimeVigilance provides an opportunity to develop expertise in drug safety and regulatory documentation.

Key Responsibilities:

  • Independently author, edit, and review regulatory/clinical documents (e.g., aggregate reports, risk management plans) while ensuring compliance with internal and external standards.
  • Participate in training programs and contribute to the development and maintenance of quality system documents for medical writing, including templates and standardized formats.
  • Provide support in pharmacovigilance operations related to medical writing.
  • Engage in continuous self-education on medical writing best practices.
  • Manage a team of junior medical writers, including mentoring and training.

Qualifications:

  • Previous experience in pharmacovigilance medical writing, including PBRERs, DSURs, and RMPs.
  • A degree in Life Sciences, nursing, or an equivalent medical qualification.
  • Strong ability to manage multiple tasks, prioritize workload, and maintain attention to detail.
  • Proven experience in mentoring and training Associate Medical Writers.
  • Advanced proficiency in English.

What We Offer:

  • Internal training and career development opportunities.
  • A strong emphasis on personal and professional growth.
  • A friendly and supportive working environment.
  • Opportunity to collaborate with colleagues worldwide, with English as the company language.
  • A diverse and inclusive workplace that values belonging, integrity, and trust.

Join us in making a positive impact on patient lives and advancing pharmacovigilance excellence!